Brigatinib Before Brain Irradiation Trial (B3i Trial)

Status Terminated

Clinical Trial Summary

This is a single arm phase II study of brigatinib alone for patients with brain metastases from anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), who have either not been treated previously with a tyrosine kinase inhibitor (TKI) targeting ALK or who have had prior exposure to crizotinib.

Clinical Trial Description

In this single-arm phase II trial, patients with brain metastases from ALK+ NSCLC will be treated with brigatinib alone without upfront brain irradiation. Patients will have close monitoring with clinical follow up visits and brain magnetic resonance imaging (MRI) surveillance, which will maximize safety and allow for early treatment if disease progression is observed. If brigatinib alone can demonstrate high rates of CNS disease control, these data could support a strategy of upfront brigatinib alone for carefully selected patients with brain metastases from ALK+ NSCLC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04634110
Study type	Interventional
Source	University of Colorado, Denver
Contact
Status	Terminated
Phase	Phase 2
Start date	November 17, 2020
Completion date	April 14, 2022

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